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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-006504-33 |
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This study will assess the efficacy and safety of Avastin combined with first li ne paclitaxel-carboplatin (cohort 1) or second line Tarceva (cohort 2) in patien ts with non-squamous non-small cell lung cancer with asymptomatic untreated brai n metastasis. Two cohorts of patients will be studied; the first will receive Av astin 15mg/kg iv every 3 weeks combined with first line paclitaxel 200mg/m2 iv p lus carboplatin AUC6 iv every 3 weeks for a maximum of 6 cycles, and the second cohort will receive Avastin 15mg/kg iv every 3 weeks combined with second line T arceva 150mg/kg po.The anticipated time on study treatment is until disease prog ression, and the target sample size is 100-500 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bevacizumab [Avastin] | Drug | 15mg/kg iv every 3 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Progression-Free Survival (PFS) Without Disease Progression or Death at 6 Months | Tumor progression was defined according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1 as increase by at least 20% in the sum of the longest diameters of each target lesion, taking as a reference the smallest sum of the longest diameters, reported since the start of treatment, or appearance of one or more new lesions. PFS (investigator assessed) was defined as the time between the first dose of study treatment and the first event of progression or death by any cause. Participants without an event were censored the last time they were known to be progression free. PFS was analyzed using the Kaplan-Meier method in each treatment arm. | 6 months |
| Percentage of Participants With Disease Progression or Death | Tumor progression was defined according to the RECIST criteria as increase by at least 20% in the sum of the longest diameters of each target lesion, taking as a reference the smallest sum of the longest diameters, reported since the start of treatment, or appearance of one or more new lesions. PFS (investigator assessed) was defined as the time between the first dose of study treatment and the first event of progression or death by any cause. Participants without an event were censored the last time they were known to be progression free. PFS was analyzed using the Kaplan-Meier method in each treatment arm. | Screening, Day 1 of Cycles 3 and 5 and every 2 cycles until end of treatment visit or disease progression or death up to 18 months after enrollment of last participant |
| Time to Disease Progression or Death | Tumor progression was defined as increase by at least 20% in the sum of the longest diameters of each target lesion, taking as a reference the smallest sum of the longest diameters, reported since the start of treatment, or appearance of one or more new lesions. Time to event was determined as the number of months between the first dose of study treatment and the first event of progression or death by any cause. PFS was analyzed using the Kaplan-Meier method in each treatment arm. | Screening, Day 1 of Cycles 3 and 5 and every 2 cycles until end of treatment visit or disease progression or death up to 18 months after enrollment of last participant |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Died | Day 1 of Cycles 1, 2, 3, 4, 5, 6 and every 3 weeks up to 18 months or until death | |
| Probability of Being Alive at 12 and 18 Months | Months 12 and 18 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bordeaux | 33076 | France | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Bevacizumab+Paclitaxel+Carboplatin | Participants received bevacizumab 15 milligrams per kilogram (mg/kg) intravenously (iv) every 3 weeks until progression or unacceptable toxicity along with paclitaxel 200 milligrams per square meter (mg/m^2) iv every 3 weeks for 6 cycles and carboplatin Area Under Curve (AUC) 6.0 milligrams per milliliter per minute (mg/mL/min) iv every 3 weeks for 6 cycles. Bevacizumab was used in addition to standard first line chemotherapy. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| carboplatin |
| Drug |
AUC6 iv every 3 weeks for 6 cycles |
|
| erlotinib [Tarceva] | Drug | 150mg/day po |
|
| paclitaxel | Drug | 200mg/m2 iv every 3 weeks for 6 cycles |
|
| Time to Death |
Time to death was determined as the number of months between the first dose of study treatment and the event of death by any cause. Overall survival was analyzed using the Kaplan-Meier method. |
| Day 1 of Cycles 1, 2, 3, 4, 5, 6 and every 3 weeks up to 18 months or until death |
| Percentage of Participants Achieving a Best Overall Response of Complete Response or Partial Response as Assessed by the Investigator Using RECIST | Overall response defined as best response according to RECIST recorded from date of randomization until disease progression or recurrence. Complete Response (CR): disappearance of all target lesions; Partial response (PR): reduction by at least 30 percent (%) of sum of the longest diameters of each target lesion, taking initial sum of longest diameters as a reference. Participants with a missing response were considered non-responders. 95% CI for one sample binomial using Pearson-Clopper method. | Screening, Day 1 of Cycles 3 and 5 and every 2 cycles until end of treatment visit or disease progression or death up to 18 months after enrollment of last participant |
| Brest |
| 29200 |
| France |
| Caen | 14076 | France |
| Chartres | 28018 | France |
| Créteil | 94010 | France |
| Gap | 05007 | France |
| Gleizé | 69400 | France |
| La Tronche | 38700 | France |
| Lille | 59020 | France |
| Lyon | 69317 | France |
| Marseille | 13273 | France |
| Marseille | 13274 | France |
| Montpellier | 34295 | France |
| Paris | 75230 | France |
| Paris | 75475 | France |
| Paris | 75674 | France |
| Paris | 75970 | France |
| Pierre-Bénite | 69495 | France |
| Rennes | 35033 | France |
| Saint-Herblain | 44805 | France |
| Strasbourg | 67065 | France |
| Toulon | 83041 | France |
| Toulouse | 31400 | France |
| Vandœuvre-lès-Nancy | 54511 | France |
| Villejuif | 94805 | France |
| FG001 | Bevacizumab+Erlotinib | Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with erlotinib150 milligrams per day (mg/day) administered as tablets orally until progression or unacceptable toxicity. Bevacizumab was used as second-line treatment in addition to erlotinib. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The Intent-to-Treat (ITT) population: All participants enrolled in each arm who had at least one post-enrollment evaluation. Participants who were lost to follow-up immediately after enrollment were not included in the ITT population.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Bevacizumab+Paclitaxel+Carboplatin | Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with paclitaxel 200 mg/m^2 iv every 3 weeks for 6 cycles and carboplatin: AUC 6.0 mg/mL/min iv every 3 weeks for 6 cycles. Bevacizumab was used in addition to standard first line chemotherapy. |
| BG001 | Bevacizumab+Erlotinib | Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with erlotinib 150 mg/day administered as tablets orally until progression or unacceptable toxicity. Bevacizumab was used as second-line treatment in addition to erlotinib. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Achieving Progression-Free Survival (PFS) Without Disease Progression or Death at 6 Months | Tumor progression was defined according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1 as increase by at least 20% in the sum of the longest diameters of each target lesion, taking as a reference the smallest sum of the longest diameters, reported since the start of treatment, or appearance of one or more new lesions. PFS (investigator assessed) was defined as the time between the first dose of study treatment and the first event of progression or death by any cause. Participants without an event were censored the last time they were known to be progression free. PFS was analyzed using the Kaplan-Meier method in each treatment arm. | ITT Population | Posted | Number | 95% Confidence Interval | percentage of participants | 6 months |
|
|
| ||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Disease Progression or Death | Tumor progression was defined according to the RECIST criteria as increase by at least 20% in the sum of the longest diameters of each target lesion, taking as a reference the smallest sum of the longest diameters, reported since the start of treatment, or appearance of one or more new lesions. PFS (investigator assessed) was defined as the time between the first dose of study treatment and the first event of progression or death by any cause. Participants without an event were censored the last time they were known to be progression free. PFS was analyzed using the Kaplan-Meier method in each treatment arm. | ITT Population | Posted | Number | percentage of participants | Screening, Day 1 of Cycles 3 and 5 and every 2 cycles until end of treatment visit or disease progression or death up to 18 months after enrollment of last participant |
| |||||||||||||||||||||||||||||||
| Primary | Time to Disease Progression or Death | Tumor progression was defined as increase by at least 20% in the sum of the longest diameters of each target lesion, taking as a reference the smallest sum of the longest diameters, reported since the start of treatment, or appearance of one or more new lesions. Time to event was determined as the number of months between the first dose of study treatment and the first event of progression or death by any cause. PFS was analyzed using the Kaplan-Meier method in each treatment arm. | ITT Population; only participants with progression or death were included in the analysis. | Posted | Median | 95% Confidence Interval | months | Screening, Day 1 of Cycles 3 and 5 and every 2 cycles until end of treatment visit or disease progression or death up to 18 months after enrollment of last participant |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Died | ITT Population | Posted | Number | percentage of participants | Day 1 of Cycles 1, 2, 3, 4, 5, 6 and every 3 weeks up to 18 months or until death |
|
| |||||||||||||||||||||||||||||||
| Secondary | Probability of Being Alive at 12 and 18 Months | ITT Population | Posted | Number | 95% Confidence Interval | percent | Months 12 and 18 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Time to Death | Time to death was determined as the number of months between the first dose of study treatment and the event of death by any cause. Overall survival was analyzed using the Kaplan-Meier method. | ITT Population; only participants with an event of death were included in the analysis. | Posted | Median | 95% Confidence Interval | months | Day 1 of Cycles 1, 2, 3, 4, 5, 6 and every 3 weeks up to 18 months or until death |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving a Best Overall Response of Complete Response or Partial Response as Assessed by the Investigator Using RECIST | Overall response defined as best response according to RECIST recorded from date of randomization until disease progression or recurrence. Complete Response (CR): disappearance of all target lesions; Partial response (PR): reduction by at least 30 percent (%) of sum of the longest diameters of each target lesion, taking initial sum of longest diameters as a reference. Participants with a missing response were considered non-responders. 95% CI for one sample binomial using Pearson-Clopper method. | ITT Population | Posted | Number | 95% Confidence Interval | percentage of participants | Screening, Day 1 of Cycles 3 and 5 and every 2 cycles until end of treatment visit or disease progression or death up to 18 months after enrollment of last participant |
|
Adverse events were recorded from the date of randomization until end of study or death.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bevacizumab+Paclitaxel+Carboplatin | Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with paclitaxel 200 mg/m^2 iv every 3 weeks for 6 cycles and carboplatin: AUC 6.0 mg/mL/min iv every 3 weeks for 6 cycles. Bevacizumab was used in addition to standard first line chemotherapy. | 27 | 67 | 67 | 67 | ||
| EG001 | Bevacizumab+Erlotinib | Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with erlotinib 150 mg/day administered as tablets orally until progression or unacceptable toxicity. Bevacizumab was used as second-line treatment in addition to erlotinib. | 7 | 24 | 24 | 24 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Febrile bone marrow aplasia | Blood and lymphatic system disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Bicytopenia | Blood and lymphatic system disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Hyperthermia | General disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Injection site extravasation | General disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Hypertensive encephalopathy | Nervous system disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (15.1) | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (15.1) | Non-systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA (15.1) | Non-systematic Assessment |
| |
| Glomerulonephropathy | Renal and urinary disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Oesophageal ulcer | Gastrointestinal disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Portal vein thrombosis | Hepatobiliary disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Peripheral artery thrombosis | Vascular disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA (15.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthenia | General disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Xerosis | General disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (15.1) | Non-systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA (15.1) | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (15.1) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Non-systematic Assessment |
|
The study being conducted under this agreement is part of the overall study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the study, but after the first publication or presentation that involves the overall study. Sponsor may request that confidential information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann- LaRoche | 1-800-821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D016190 | Carboplatin |
| D000069347 | Erlotinib Hydrochloride |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
Not provided
Not provided
| Male |
|
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| Participants |
|
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